People Operations

• 開発品安全性業務
• 申請時電子添文「使用上の注意」、J-RMP(安全性検討事項、安全性監視計画、リスク最小化策)の立案、作成
• CTDの関連パート作成、審査対応
• 製造販売後調査プロトコル作成
• 最適使用推進ガイドライン(GL) 作成・改訂
• 市販品安全性業務
• 集積情報等にもとづく安全確保措置の検討
• 電子添文、J-RMP改訂要否検討及び改訂案作成(PMDA、米国本社及び国内他社等との交渉/相談含む)
• 情報提供資材の作成・改訂
• 製造販売後調査のプロトコル改訂
• 安全性定期報告書及び再審査申請資料の安全性パート作成
• 市販後安全対策全般に関する外部医学専門家とのコミュニケーション、各学会対応

Associate Director, R&D PV Safety Risk Management

• Establish strong partnerships with leaders in Japan to align people strategy with business goals and foster high-performance and people centric culture
• Lead and support organizational design or change initiatives to support organizational effectiveness
• Strengthen leadership capability across the organization through L&D solutions and coaching
• Coach managers and senior leaders on leadership effectiveness, feedback, and team dynamics
• Drive performance management, talent reviews, succession planning processes and other global People Business Partnership programs
• Facilitate and influence organizational and leadership discussions through People Business Partner expertise and data-driven insights
• Act as a trusted escalation point for employee relations matters and support managers in resolving them smoothly.
• Work with the global People & Culture Team and contribute to Drivemode employee lifecycle and experience development.

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Associate Director, R&D PV Safety Risk Management

Staff People Business Partner